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Pharmaceutical composition containing levosimendan or its pharmaceutically acceptable salt as active ingredient

An active ingredient and pharmaceutical technology, applied in the field of pharmaceutical preparations, can solve problems such as unreported, coagulation side effects, etc., and achieve the effect of low toxicity and safe medication for patients

Inactive Publication Date: 2006-10-04
成都英创科技发展有限责任公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In 2000, the drug solution of levosimendan was developed by Orion Company and applied for a patent in China, but the solubilizer polyvinylpyrrolidone or other surfactants used in it have been clinically proven to have blood coagulation side effects , which poses a risk to the patient
[0009] Solutol  HS15 is used to prepare levosimendan solution preparations, which has not been reported so far

Method used

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  • Pharmaceutical composition containing levosimendan or its pharmaceutically acceptable salt as active ingredient
  • Pharmaceutical composition containing levosimendan or its pharmaceutically acceptable salt as active ingredient

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] Example 1 Levosimendan Injection

[0048] Component Amount (g)

[0049] Levosimendan 2.5g

[0050] Solutol® HS15 10g

[0051] Anhydrous citric acid 2g

[0052] Add absolute ethanol to 1000ml

[0053] A concentrated solution was prepared by dissolving citric acid, Solutol(R) HS15 and levosimendan in absolute ethanol in a sterile formulation container. The resulting bulk solution was filtered through a sterile filter (0.22 μm). The sterilization method of this product is sterile filtration, because ethanol solution has the risk of explosion and cannot be sterilized by autoclaving. The sterile-filtered bulk solution was aseptically filled into vials for injection and closed with Dacron membrane rubber stoppers for infusion.

Embodiment 2

[0054] Example 2 Levosimendan Oral Liquid

[0055] Component Dosage

[0056] Levosimendan 12.5mg

[0057] Solutol® HS15 30mg

[0058] Absolute ethanol 2.5ml

[0059] Corn oil" 10ml

[0060] Makes 12ml

[0061] The levosimendan composition is mixed with corn oil, and stirred evenly under stirring conditions to obtain a clear oily liquid, which can be used as an oral liquid or soft capsule as the content of the soft capsule.

Embodiment 3

[0063] Component Dosage

[0064] Levosimendan 12.5mg

[0065] Mannitol 280mg

[0066] Solutol® HS15 50mg

[0067] 0.2mol / L disodium hydrogen phosphate 1.46ml

[0068] 0.2mol / L sodium dihydrogen phosphate 0.14ml

[0069] Add water for injection to 3ml

[0070] Take levosimendan, Solutol(R) HS15, mannitol, add disodium hydrogen phosphate and sodium dihydrogen phosphate solution, stir to dissolve completely (PH is 7.8), add 3 mg of activated carbon, continue stirring for 30 min, decarbonize, add water for injection to set Make up to 3ml, 0.22um microporous membrane filter to sterilize. Under aseptic conditions, the obtained solution is placed in a sterile vial, freeze-dried in a freeze dryer, and sealed. That is, the yellow levosimendan freeze-dried powder preparation of the present invention is obtained.

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PUM

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Abstract

The invention relates to a pharmaceutical composition, wherein each unit dosage comprises: (1) 5-50mg of Levosimendan or its pharmaceutically acceptable salt, (2) 10-200mg of Solutol HS 15, (3) 0.1-1000ml of medicinal solvent.

Description

technical field [0001] The invention relates to a pharmaceutical preparation, in particular to a solution preparation of levosimendan, an anti-heart failure medicine. The problem of safety and stability of intravenous administration is solved. Background technique [0002] Levosimendan, chemical name [(-)-[4-(1,4,5,6-tetrahydro-4-methyl-6-oxo-3-pyridazinyl)phenyl]hydrazono] Malononitrile, a drug that is effective in the treatment of congestive heart failure. Levosimendan is effective in the treatment of heart failure and has a significant calcium dependence associated with troponin. Levosimendan is represented by the following formula: [0003] [0004] Levosimendan is a drug that is poorly soluble in water. Sundberg, 5. et al., in Am. J. Cardiol., 1995; 75: 1061-1066, recorded the hemodynamic effects of levosimendan on human body. Sandell, E-P. et al., J. cardiovasc. Pharmacol., 26 (suppl. 1), 557-562, 1995, describe the pharmacokinetics of levosimendan after intraven...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/50A61K9/06A61K9/08A61K9/10A61K9/48A61P9/04
Inventor 王成韩晓彤代丽萍吴庆江李思成
Owner 成都英创科技发展有限责任公司
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